About this trial
This randomized, multicenter, open-label trial evaluates whether preoperative dental screening improves outcomes in patients undergoing surgical or transcatheter cardiac valve intervention. Participants are randomized 1:1 to preoperative dental screening or no screening. The primary outcome is time to first occurrence of all-cause death, redo-intervention of the index valve, or definite infective endocarditis within 2 years. The study uses registry-based follow-up to ensure complete outcome ascertainment.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years
Accepted for cardiac valve intervention
Able to provide informed consent
Disqualifiers
Previous or ongoing infective endocarditis
Urgent surgery
Pain from loose tooth/teeth
Immunosuppressive therapy (excluding corticosteroids)
Trial design
Parallel
Treatments tested in this trial
Preoperative dental screening
Other interventionDental examination prior to valve intervention; treatment performed if indicated.
No preoperative dental screening
Other interventionNo routine dental screening prior to valve intervention.
Treatment groups
Trial outcomes
Primary outcomes
Composite outcome of death, redo-intervention, or infective endocarditis
Time to first occurrence of all-cause death, redo-intervention of the index valve, or definite infective endocarditis.
Secondary outcomes
All-cause mortality
Redo-intervention of index valve
Definite infective endocarditis
CIED extraction
Extraction of Cardiovascular Implantable Electronic Device (CIED)
Sponsors and contacts
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